Introduction: The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.
Methods: The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar®). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.
Results: Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar® group compared to the control group (-0.16 vs. -0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (-1.4 ± 10.0 vs. -3.9 ± 12.5, p = 0.32).
Conclusion: The use of iBGStar® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.
Clinical trial registration: ClinicalTrials.gov: NCT01825382.
Funding: Sanofi.
Keywords: Continuous glucose monitoring; Diabetes; Glucometer; Hypoglycemia; Mobile technology; Self-monitoring of blood glucose; Type 1 diabetes; iBGStar; iPhone.